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Completed

NCT Number: NCT06550440

The Impact of Family Integrated Care on Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants

To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.

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Key information

Conditions

Very Low Birth Weight Infant

Age range

28 week–32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.Very low birth weight infants admitted to 17 neonatal intensive care units in 8 provinces and cities in southeast China from February 2021 to November 2023 were retrospectively included, which were divided into case group and control group according to whether there was extrauterine growth restriction (defined as the weight below the 10th percentile of children of the same age at discharge). The general situation at birth, the length of hospital stay, the incidence of complications during hospital stay, the feeding situation, the length of family participation care and the perinatal situation of the mother were compared between the two groups. The generalized linear mixed model was used to analyze the influencing factors of extrauterine growth retardation at discharge, and the results of influencing factors were visualized by GraphPad Prism 9.0 software.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborns admitted to 17 units in 8 provinces from February 2021 to November 2023;
  • Birth weight < 1500 g, gestational age < 32 weeks;
  • admitted in NICU within 24 hours after birth;
  • premature infants without complications (including bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, intraventricular hemorrhage and late-onset septicemia) at the time of admission.

Exclusion criteria

  • death occurred during hospitalization;
  • Incomplete outcome data (lack of EUGR data at discharge).

Treatment and study plan

family integrated care

Behavioral

Trained NICU nurses give effective education to parents of children, and regard parents as a part of NICU team, so that they can actively provide positive care for babies instead of passive caregivers. Parents mainly participate in nursing care such as bottle feeding, changing diapers, skin contact and so on.

Primary outcomes

  1. total duration of family integrated care

    Time frame: From the day admitted into the NICU until day on discharge，an average of 2 months.

    Trained NICU staffs effectively educate parents as part of the NICU team so that they can proactively provide active care for the baby, rather than passive caregivers. Parents are primarily involved in care such as bottle feeding, diaper changing, skin-to-skin contact and so on.We calculate total duration of family integrated care in hours.

Secondary outcomes

  1. Birth weight

    Time frame: assessed at birth.

    birth weight in grams

  2. Small for gestational age

    Time frame: assessed at birth.

    birth weight<10th percentile of the neonatal growth curve for infants of the same sex and gestational age

  3. Necrotizing enterocolitis

    Time frame: From the day admitted into the NICU until day on discharge, an average of 2 months.

    diagnosed according to the Bella classification

  4. gestational age

    Time frame: assessed at birth.

    gestational age at weeks

Other outcomes

  1. Bronchopulmonary dysplasia

    Time frame: From the day admitted into the NICU until day on discharge，an average of 2 months.

    oxygen is required at 36 weeks of corrected gestational age or at discharge

  2. Retinopathy of prematurity

    Time frame: From the day admitted into the NICU until day on discharge, an average of 2 months.

    diagnosed according to the International Classification of Retinopathy of Prematurity

  3. Intraventricular hemorrhage

    Time frame: From the day admitted into the NICU until day on discharge，an average of 2 months.

    the diagnosis is based on Paplie's classification

  4. Late-onset sepsis

    Time frame: From the day admitted into the NICU until day on discharge, an average of 2 months.

    sepsis occurs >72h after birth

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

The Impact of Family Integrated Care on the Occurrence of Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants: a Multicenter, Retrospective Case-control Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 13, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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